MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-475-14

Device Problem Activation Failure (3270)

Patient Problems Hemorrhage, Cerebral (1889); Dysphasia (2195); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.The device involved in this event is not approved in the us; the device's brand name and model number are provided below.This report is being filed against a similar device.Brand name: pipeline flex with shield technology model number: ped2-475-14.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic flow diverter did not open distally despite several attempts to open by resheathing.The medtronic flow diverter was replaced with another medtronic flow diverter to complete the procedure.Post procedural angiography showed good stasis in both aneurysms.No patient injury was reported as a result of the event.Prior to the event, approximately ¼ of the medtronic flow diverter was deployed.The medtronic flow diverter did not flare distally so the physician attempted to open it by resheathing it 3-4 times.At this point, the medtronic flow diverter looked abnormal, so a decision was made to remove the entire flow diverter with the microcatheter and replace with new one.The patient was undergoing embolization of a saccular aneurysm measuring 3.5mm x 3.2mm located in the pcom origin of the left internal carotid artery (ica).The physician was unsure of the status (if patient had bleed) of the aneurysm.The distal and proximal landing zone was 4.2mm x 4.3mm.The patient¿s vasculature was moderate in tortuosity.The patient was on dual antiplatelet therapy.There are no images for review.The medtronic flow diverter was not placed on a bend and no additional steps were taken to attempt to open it.

Event Description

Additional information received reported that patient experienced a small stroke with dysarthria.The patient was expected to recover with rehab.The likely cause of the stroke was due to the length of the procedure and was said to not likely be embolic as the patient was given prasugrel.There was no mention of unexpected resistance in the procedure.It was also reported that the microcatheter was initially discarded, but the manufacturer representative was able to recover it post procedure.There was a visible kink in the distal part of the microcatheter, and it was unknown if this occurred during the procedure or if it was damaged after it was discarded.

Manufacturer Narrative

H6: upon further review, patient code c76143 no longer applies.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10187891
• MDR Text Key: 198142035
• Report Number: 2029214-2020-00589
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: A865240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR